Michael Barbella, Managing Editor03.20.24
Nalu Medical Inc. has released results of the SCS nPower U.S. clinical study that evaluated use of the Nalu SCS System to treat patients suffering from chronic intractable trunk and/or limb pain, including unilateral or bilateral pain.
The SCS nPower US clinical study was a prospective, post-market observational study conducted at 15 U.S. comprehensive pain centers. The trial evaluated the Nalu Neurostimulation System in 35 subjects with chronic low back and leg pain from baseline to three months. Highlights of the results include:
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. The Nalu micro-IPG delivers treatment capabilities similar to larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an 18-year expected service life. The Nalu System has been repeatedly recognized for its technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021. It is U.S. Food and Drug Administration-cleared for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications.
“In addition to strong clinical outcomes, the Nalu SCS System offers interventional pain specialists a treatment option that traditional SCS systems do not provide: a micro-IPG paired with a wearable battery. The risks and costs associated with repeated IPG replacement procedures are significantly reduced, while battery replacement surgeries are entirely eliminated," Nalu Medical CEO Tom West stated. "The nPower study results in SCS reflect Nalu’s commitment to providing differentiated clinical and health-economic evidence to support the adoption and use of our neurostimulation system for chronic intractable pain in both spinal cord stimulation and peripheral nerve stimulation.”
Nalu is a Carlsbad, Calif.-based medical technology company developing and commercializing minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu System was designed to address major unmet needs in treating chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.
The SCS nPower US clinical study was a prospective, post-market observational study conducted at 15 U.S. comprehensive pain centers. The trial evaluated the Nalu Neurostimulation System in 35 subjects with chronic low back and leg pain from baseline to three months. Highlights of the results include:
- Eighty-six percent of subjects were “responders” (≥50% pain relief) in the low back and leg(s).
- Fifty-four percent of subjects in the low back and 49% in the leg(s) were “high responders” (≥80% pain relief).
- Seventy-five percent average pain reduction in the low back and 76% in the leg(s).
- All patients said the wearable Therapy Disc was comfortable and easy to use.
- Secondary endpoints for sleep, mood, functional disability, and quality of life all demonstrated statistically significant outcomes at three months compared with baseline.
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. The Nalu micro-IPG delivers treatment capabilities similar to larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an 18-year expected service life. The Nalu System has been repeatedly recognized for its technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021. It is U.S. Food and Drug Administration-cleared for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications.
“In addition to strong clinical outcomes, the Nalu SCS System offers interventional pain specialists a treatment option that traditional SCS systems do not provide: a micro-IPG paired with a wearable battery. The risks and costs associated with repeated IPG replacement procedures are significantly reduced, while battery replacement surgeries are entirely eliminated," Nalu Medical CEO Tom West stated. "The nPower study results in SCS reflect Nalu’s commitment to providing differentiated clinical and health-economic evidence to support the adoption and use of our neurostimulation system for chronic intractable pain in both spinal cord stimulation and peripheral nerve stimulation.”
Nalu is a Carlsbad, Calif.-based medical technology company developing and commercializing minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu System was designed to address major unmet needs in treating chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.